Developmental stage and morphology of the competent blastocyst are associated with sex of the child but not with other obstetric outcomes: a multicenter cohort study.

STUDY QUESTION: Are transfer day, developmental stage and morphology of the competent blastocyst in pregnancies leading to live birth associated with preterm birth, birthweight, length at birth and sex of the child? SUMMARY ANSWER: A high score in blastocyst developmental stage and in trophectoderm (TE) showed a significant association with the sex of the child, while no other associations with obstetric outcomes were observed. WHAT IS KNOWN ALREADY: The association between blastocyst assessment scores and obstetric outcomes have been reported in small single-center studies and the results are conflicting. STUDY DESIGN, SIZE, DURATION: Multicenter historical cohort study based on exposure data (transfer day (blastocyst developmental stage reached by Day 5 or Day 6)) blastocyst developmental stage (1-6) and morphology (TE and inner cell mass (ICM): A, B, C)) and outcome data (preterm birth, birthweight, length at birth, and sex of the child) from women undergoing single blastocyst transfer resulting in a singleton pregnancy and live birth. PARTICIPANTS/MATERIALS, SETTING, METHODS: Data from 16 private and university-based facilities for clinical services and research were used. A total of 7246 women, who in 2014-2018 underwent fresh-embryo transfer with a single blastocyst or frozen-thawed embryo transfer (FET) with a single blastocyst resulting in a singleton pregnancy were identified. Linking to the Danish Medical Birth Registry resulted in a total of 4842 women with a live birth being included. Cycles with pre-implantation genetic testing and donated gametes were excluded. The analyses were adjusted for female age (n = 4842), female BMI (n = 4302), female smoking (n = 4290), parity (n = 4365), infertility diagnosis (n = 4765), type of treatment (n = 4842) and center (n = 4842); some analyses additionally included gestational age (n = 4368) and sex of the child (n = 4833). MAIN RESULTS AND THE ROLE OF CHANCE: No statistically significant associations between blastocyst assessment scores (transfer day, developmental stage, TE, ICM) and preterm birth (8.3%) or birthweight (mean 3461.7 g) were found. The adjusted association between blastocysts with a TE score of C and a TE score of A and length at birth (mean 51.6 cm) were statistically significant (adjusted mean difference 0.4 cm (95% CI: 0.02; 0.77)). Blastocysts transferred with developmental stage score 5 compared to blastocysts transferred with score 3 had a 34% increased probability of being a boy (odds ratio (OR) 1.34 (95% CI: 1.09; 1.64). Further, TE score B blastocysts compared to TE score A blastocysts had a 31% reduced probability of being a boy (OR 0.69 (95% CI: 0.60; 0.80)). LIMITATIONS, REASONS FOR CAUTION: It is possible that some residual confounding remains. WIDER IMPLICATIONS OF THE FINDINGS: Blastocyst selection during ART does not appear to introduce any negative effects on obstetric outcome. Therefore, clinicians and patients can be reassured that the assessment scores of the selected blastocyst will not in themselves pose a risk of preterm birth or affect birthweight and the length at birth. STUDY FUNDING/COMPETING INTEREST(S): Unrestricted grant from Gedeon Richter Nordics AB, Sweden. None of the authors have any competing interest to declare. TRIAL REGISTRATION NUMBER: N/A.

Surgical repair of parastomal bulging: a retrospective register-based study on prospectively collected data.

AIM: The aim of this work was to examine (1) the incidence of primary repair, (2) the incidence of recurrent repair and (3) the types of repair performed in patients with parastomal bulging. METHOD: Prospectively collected data on parastomal bulging from the Danish Stoma Database were linked to surgical data on repair of parastomal bulging from the Danish National Patient Register. Survival statistics provided cumulative incidences and time until primary and recurrent repair. RESULTS: In the study sample of 1016 patients with a permanent stoma and a parastomal bulge, 180 (18%) underwent surgical repair. The cumulative incidence of a primary repair was 9% [95% CI (8%; 11%)] within 1 year and 19% [95% CI (17%; 22%)] within 5 years after the occurrence of a parastomal bulge. We found a similar probability of undergoing primary repair in patients with ileostomy and colostomy. For recurrent repair, the 5-year cumulative incidence was 5% [95% CI (3%; 7%)]. In patients undergoing repair, the probability was 33% [95% CI (21%; 46%)] of having a recurrence requiring repair within 5 years. The main primary repair was open or laparoscopic repair with mesh (43%) followed by stoma revision (39%). Stoma revision and repair with mesh could precede or follow one another as primary and recurrent repair. Stoma reversal was performed in 17% of patients. CONCLUSION: Five years after the occurrence of a parastomal bulge the estimated probability of undergoing a repair was 19%. Having undergone a primary repair, the probability of recurrent repair was high. Stoma reversal was more common than expected.

Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial).

BACKGROUND: A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study was to compare health-related quality of life (HRQOL) following early versus late closure of a temporary ileostomy. METHODS: Early closure of a temporary ileostomy (at 8-13 days) was compared with late closure (at more than 12 weeks) in a multicentre RCT (EASY) that included patients who underwent rectal resection for cancer. Inclusion of participants was made after index surgery. Exclusion criteria were signs of anastomotic leakage, diabetes mellitus, steroid treatment, and signs of postoperative complications at clinical evaluation 1-4 days after rectal resection. HRQOL was evaluated at 3, 6 and 12 months after resection using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-CR29 and Short Form 36 (SF-36®). RESULTS: There were 112 patients available for analysis. Response rates of the questionnaires were 82-95 per cent, except for EORTC QLQ-C30 at 12 months, to which only 54-55 per cent of the patients responded owing to an error in questionnaire distribution. There were no clinically significant differences in any questionnaire scores between the groups at 3, 6 or 12 months. CONCLUSION: Although the randomized study found that early closure of the temporary ileostomy was associated with significantly fewer complications, this clinical advantage had no effect on the patients' HRQOL. Registration number: NCT01287637 (https://www.clinicaltrials.gov).

Incidence and risk factors for parastomal bulging in patients with ileostomy or colostomy: a register-based study using data from the Danish Stoma Database Capital Region.

AIM: The aim was to investigate the incidence and risk factors for parastomal bulging, a clinically important complication, in patients with an ileostomy or colostomy. METHOD: The Danish Stoma Database Capital Region prospectively collects data on patients with a stoma up to a year after surgery. Stoma care nurses clinically assessed the main outcome, parastomal bulging. We linked data from the Stoma Database to data from the Danish Anaesthesia Database. Cumulative incidence of parastomal bulging over the first year was calculated with death and stoma reversal as competing risks. Risk factors were investigated using an exploratory approach. RESULTS: In a study population of 5019, the cumulative incidence (with competing risks) of parastomal bulging was 36.2% at 400 days after surgery. Age, colostomy, male gender, alcohol consumption and laparoscopy were associated with an increased risk of parastomal bulging. Compared with cancer, inflammatory bowel disease was associated with a lower risk of parastomal bulging, and diverticulitis was associated with a higher risk. Peristomal mesh and stomas placed through a separate incision were associated with a reduction in risk. There was neither increased nor decreased risk of parastomal bulging for body mass index, American Society of Anesthesiologists score, smoking status, emergency surgery and preoperative stoma site marking. CONCLUSION: Parastomal bulging is a common complication affecting one in three patients within 1 year of surgery. Along with previous findings, there is now considerable evidence for age and colostomy as being risk factors for parastomal bulging.

Establishment of a regional Danish database for patients with a stoma.

AIM: To present the Danish Stoma Database Capital Region with clinical variables related to stoma creation including colostomy, ileostomy and urostomy. METHOD: The stomatherapists in the Capital Region of Denmark developed a database covering patient identifiers, interventions, conditions, short-term outcome, long-term outcome and known major confounders. The completeness of data was validated against the Danish National Patient Register. RESULTS: In 2013, five hospitals included data from 1123 patients who were registered during the year. The types of stomas formed from 2007 to 2013 showed a variation reflecting the subspecialization and surgical techniques in the centres. Between 92 and 94% of patients agreed to participate in the standard programme aimed at handling of the stoma and more than 88% of patients having planned surgery had the stoma site marked pre-operatively. CONCLUSION: The database is fully operational with high data completeness and with data about patients with a stoma from before surgery up to 12 months after surgery. The database provides a solid basis for professional learning, clinical research and benchmarking.

Patient education has a positive effect in patients with a stoma: a systematic review.

AIM: A systematic review was performed to assess whether education of patients having stoma formation improves quality of life and whether it is cost effective. METHOD: A literature search was performed to identify studies on the structured education of ostomates and outcome using the following databases: MEDLINE, Cinahl, Embase, Cochrane and PsycInfo. Inclusion criteria were: clinical studies reporting effects of educational interventions in relation to patients with a stoma. Commentaries or studies not testing an intervention were excluded. RESULTS: Seven articles met the inclusion criteria of having rigorously evaluated an educational programme related to living with a stoma. The programmes were organized in different ways and had explored various interventions. The results showed an increase in health-related quality of life, as measured using a stoma quality of life instrument (P = 0.00001) and with the Short Form 36 (SF-36) (P = 0.000-0.006), an increase in proficiency in management of the stoma (P = 0.0005), two studies pointed to a reduction in postoperative hospital stay (8 days vs 10 days, P = 0.029; and 8 days vs 14 days, P = 0.17), a significant reduction in cost in the intervention group ($US 8570.54) compared with the control group ($US 7396.90) as well as higher effectiveness scores in the intervention group (166.89) compared with the control group (110.98), a significant rise in stoma-related knowledge (P = 0.0000) and an increase in psychosocial adjustment (P = 0.000). CONCLUSION: Structured patient education aimed at patients' psychosocial needs seems to have a positive effect on quality of life as well as on cost. The interventions may be performed before, during or after hospital stay. However, the available data come from few studies with differences in interventions and in study design, and further studies are therefore needed before a final conclusion can be drawn.

Oncology patients' experience of a routine surveillance CT examination: Relationships and communication.

INTRODUCTION: The question of radiographers' capacity to establish short time relationships as well as decoding patients' needs and expectations simultaneously with performing high technological examination frequently arises in the clinical practice. Additionally, the constant focus on technology and the fact that radiographers work in high productive departments accentuates the issue. Patients' experiences with radiology seem to be a neglected area of research and may help to identify areas for improvement in this highly technological and productive field. The purpose of the study was to explore oncology patients' experiences of a routine surveillance CT examination and their need for relationships and communication with the radiographer as part of the CT examination. METHODS: The study included patients diagnosed with cancer and in need of a CT examination as part of their course of treatment, and 21 semi-structured interviews were conducted. The interviews were analysed using qualitative content analysis. Themes were constructed and narratively reported. To increase validity, the themes were identified, discussed and formulated by the author group. RESULTS: Four themes were constructed based on the analysis: 1: The professional radiographer, 2. Disease and treatment, 3. The examination environment and 4: While waiting. CONCLUSION: The lack of focus on radiographers' capacity to establish relations, to consider each patient as an individual human being and being able to show sincere interest and empathy were highlighted. Findings illuminated the patient's need for relationship and communication with the radiographer as part of a CT examination.

The therapeutic or prophylactic effect of exogenous melatonin against depression and depressive symptoms: a systematic review and meta-analysis.

Circadian- and sleep disturbances may be central for understanding the pathophysiology and treatment of depression. The effect of melatonin on depression/depressive symptoms has been investigated previously. This systematic review assesses the current evidence of a therapeutic- and prophylactic effect of melatonin in adult patients against depression or depressive symptoms. A search was performed in The Cochrane Library, PubMed, EMBASE and PsycINFO for published trials on November 14th 2013. Inclusion criteria were English language, RCTs or crossover trials. Our outcome was measurement of depression/depressive symptoms with a validated clinician-administered or self-rating questionnaire. PRISMA recommendations were followed and the Cochrane risk-of-bias tool used. Ten studies in 486 patients were included in the final qualitative synthesis and four studies, 148 patients, were included in two meta-analyses. Melatonin doses varied from 0.5-6 mg daily and the length of follow-up varied from 2 weeks to 3.5 years. Three studies were done on patients without depression at inclusion, two studies in patients with depression and five studies included a mixture. Six studies showed an improvement in depression scores in both the melatonin and placebo groups but there was no significant difference. One study showed a significant prophylactic effect and another found a significant treatment effect on depression with melatonin compared to placebo. The two meta-analyses did not show any significant effect of melatonin. No serious adverse events were reported. Although some studies were positive, there was no clear evidence of a therapeutic- or prophylactic effect of melatonin against depression or depressive symptoms.